Microbiological Quality Control Services

Microbiological Quality Control Services

Pharmaceutical companies to comply with GMP are required to assess clean rooms and controlled environments for microbiological contamination to establish they are fit for purpose as classified in the table below:

Clean Area Classification (0.5 µm particles/ft3)

ISO Designation 14644-1

Microbiological Active Air Action Levels (CFU/m3)

100

ISO 5

1

1000

ISO 6

7

10000

ISO 7

10

100000

ISO 8

100

Microbiological environmental monitoring of production or support areas ensures that the Quality Control Checks are in place to identify any possible sources of contamination and to establish it is under a state of control.